September 20, 2015
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Updated assay shows more accuracy in detecting TB

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SAN DIEGO — Researchers from Japan reported at ICAAC 2015 that they have invented an updated, more accurate version of a screening assay that detects tuberculosis infection.

“We found a new generation of QuantiFERON TB Gold In-Tube (Cellestis; QFT-GIT) assay … [that] could replace the current QFT-GIT,” Lina Yi, MD, of Fukujuji Hospital in Tokyo, and colleagues wrote.

The researchers collected blood samples from 162 patients with tuberculosis (mean age, 55 years) and 216 participants with low risk for tuberculosis (mean age, 20.7 years) from seven institutions and six hospitals. Yi and colleagues reported that the updated technology detected TB infection with a specificity of 97.6% in patients who tested positive for TB and found no infection in 98.1% of participants who tested negative.

By comparison, the current QFT-GIT has a specificity of 99% for TB in patients testing positive for the infection and a sensitivity of 89% in patients testing negative for TB, according to the FDA.

WHO reported that one-third of the global population is infected with tuberculosis and that 10% of those infected develop active disease, according to a press release. Using the updated QFT-GIT assay would identify many of those infected with latent tuberculosis, allowing them to be treated before getting active disease.

“These findings could have a significant impact on detecting TB infection around the world,” Yi and colleagues wrote. – by Will Offit

References:

Yi L, et al. Abstract D-684. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 17-21, 2015; San Diego.

FDA. QuantiFERON®-TB Gold (In-Tube Method) package insert. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/UCM260551.pdf. Accessed Sept. 15, 2015.

Disclosure: Yi reports being a research contractor for Cellestis, a Qiagen company. Please see the abstract for a list of all other authors’ relevant financial disclosures.